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Platelets Antiaggregation Control Enhancement (PACE) Study (PACE)

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ClinicalTrials.gov Identifier: NCT01218074
Recruitment Status : Terminated
First Posted : October 11, 2010
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Luca Weltert, Cardiochirurgia E.H.

Brief Summary:
Many patients undergo cardiac surgery without proper suspension of antiaggregation drugs. This is blamed to increase dramatically bleeding and use of allogenic blood transfusions. The investigators test the hypothesis that routine use of aggregometry could show antiaggregated patient and lead to normalization of platelet function via administration of Desmopressin thus limiting bleeding and transfusions.

Condition or disease Intervention/treatment
Bleeding Blood Transfusion Device: Aggregometry+Thromboelastography Device: Thromboelastography Alone

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Platelets Antiaggregation Control Enhancement Study: an Independent Randomized Blind Prospective Study
Study Start Date : December 2010
Primary Completion Date : September 2016
Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Thromboelastography alone
Patients undergo standard of care Thromboelastography to evaluate overall coagulation performances.
Device: Thromboelastography Alone
Patients undergo standard of care Thromboelastography to evaluate overall coagulation performance.
Experimental: Aggregometry+Tromboelastography
Patients undergo standard thromboelastography and subsequent aggregometry to test effectiveness of residual antiaggregation drugs. Patients found to have altered value undergo optimization with desmopressin.
Device: Aggregometry+Thromboelastography
Patients undergo standard thromboelastography and subsequent aggregometry to test effectiveness of residual antiaggregation drugs. Patients found to have altered value undergo optimization with desmopressin.



Primary Outcome Measures :
  1. Bleeding Volume [ Time Frame: 12 hours after end of operation ]
    Total amount of bleeding in the first 12 hours after cardiac surgery expressed as milliliters of blood in the chest drains reservoir.


Secondary Outcome Measures :
  1. Use of allogenic blood transfusions. [ Time Frame: In hospital stay (usually 5 to 8 days after operation) ]
    Number of allogenic blood units transfused per patients during the full hospital stay, usually 5 to 8 days after operation.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all patients undergoing surgical myocardial revascularization.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01218074


Locations
Italy
European Hospital
Rome, Italy, 00149
Sponsors and Collaborators
Cardiochirurgia E.H.

Responsible Party: Luca Weltert, Project Leader Luca Weltert, Cardiochirurgia E.H.
ClinicalTrials.gov Identifier: NCT01218074     History of Changes
Other Study ID Numbers: 00-04
First Posted: October 11, 2010    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018

Keywords provided by Luca Weltert, Cardiochirurgia E.H.:
bleeding
blood sparing procedure
desmopressin
aggregometry
thromboelastography

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs